What side effects are associated with this type of intervention?

Common side effects for treatments aimed at lowering high levels of fat in the blood, such as PCSK9 inhibitors, include mild local injection site reactions like erythema, pain, or bruising. Other potential side effects can include hypersensitivity reactions such as rash, pruritus, and urticaria. Serious adverse effects are uncommon, and muscle toxicity or elevated liver enzymes are not typically observed. Neurocognitive symptoms have been reported in less than 1% of patients.

What prior FDA approvals exist?

Prior FDA approvals for treatments targeting high levels of fat in the blood include statins like atorvastatin and simvastatin, which are used to lower cholesterol levels. Additionally, PCSK9 inhibitors such as evolocumab and alirocumab have been approved to reduce LDL cholesterol. These drugs have demonstrated efficacy in lowering lipid levels and reducing cardiovascular events in patients with hyperlipidemia.

What other types of research exist?

Promising novel alternatives to NNC0491-6075 for treating high levels of fat in the blood include PCSK9 inhibitors (e.g., evolocumab, alirocumab), which have shown significant efficacy in lowering LDL cholesterol. Another alternative is bempedoic acid, which is an ATP citrate lyase inhibitor that also helps reduce LDL cholesterol levels. Additionally, inclisiran, a small interfering RNA (siRNA) therapy that targets PCSK9 synthesis, has shown promise in clinical trials for its long-lasting effects on cholesterol reduction.

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NNC0491-6075 for High Cholesterol

Phase 1

Recruiting

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Part B: Men or women of non-childbearing potential aged 18-64 years at the time of signing informed consent, with dyslipidaemia at screening, considered generally healthy based on medical history, physical examination, and results of vital signs, electrocardiogram, and clinical laboratory tests, with BMI between 18.5 and 34.9 kg/m^2 at screening. If on statin therapy, the dose must have been stable for at least 8 weeks before screening and must be intended to remain stable throughout the study.

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from pre-dose (day 22) to 168 hours after last dose (day 29)

Summary

This trial is testing a new medicine to see if it can safely lower high levels of fat in the blood. It involves healthy individuals, people with high blood fat, and healthy Japanese participants. The medicine is given as an injection or through a vein to understand its effects and safety.

Who is the study for?

This trial is for healthy adults aged 18-55, or those with high fat levels in the blood aged 18-64. Participants must have a BMI of 18.5 to 34.9 kg/m^2 and stable health as confirmed by medical exams. Those on statins must be on a steady dose for at least 8 weeks prior.

What is being tested?

The study tests NNC0491-6075's safety and how it works in the body compared to a placebo. It has three parts: single-dose effects in healthy people (Part A), weekly doses for four weeks in people with high fat levels (Part B), and single-dose effects in healthy Japanese participants (Part C).

What are the potential side effects?

As this is an early-stage trial testing a new medication, potential side effects are not fully known but may include reactions at injection sites, general discomfort, or other unexpected symptoms related to the medicine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18-64, healthy with stable cholesterol treatment, and my BMI is between 18.5 and 34.9.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from pre-dose (day 22) to 168 hours after last dose (day 29)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from pre-dose (day 22) to 168 hours after last dose (day 29)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from pre-dose (day 22) to 168 hours after last dose (day 29) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A (SAD): Number of treatment emergent adverse events (TEAEs)

Part B (MAD): Number of treatment emergent adverse events (TEAEs)

Part C (SAD): Number of treatment emergent adverse events (TEAEs)

Secondary study objectives

Part A (SAD): AUC0-∞, SD; the area under the NNC0491-6075 serum concentration-time curve from 0 to infinity after a single dose

Part A (SAD): Cmax, SD; the maximum serum concentration of NNC0491-6075 after a single dose

Part A (SAD): tmax, SD; The time to maximum concentration of NNC0491-6075 after a single-dose (only from subcutaneous administration)

+9 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part C: Single ascending dose (SAD) cohorts in healthy Japanese participants:Experimental Treatment2 Interventions

Healthy Japanese participants, randomized in the ratio 3:1 in each of the cohorts will receive single ascending dose of either NNC0491-6075 or placebo in 3 cohorts (Cohort C1,C2 and C3). The route of administration will be subcutaneous or intravenous.

Group II: Part B Multiple ascending dose (MAD) cohorts in dyslipidemia participantsExperimental Treatment2 Interventions

Participants with dyslipidemia, randomized in the ratio 2:1 in each of the cohorts will receive multiple ascending dose of either NNC0491-6075 or placebo in 3 cohorts (Cohort B1,B2 and B3). Participants will receive subcutaneous injections of either NNC0491-6075 or placebo once weekly for 4 weeks.

Group III: Part A Single ascending dose (SAD) cohorts in healthy participants:Experimental Treatment2 Interventions

Healthy participants, randomized in 3:1 ratio in each of the cohorts will receive single ascending dose of either NNC0491-6075 or placebo in 5 cohorts (Cohort A1, A2, A3, A4 and A5). In cohorts A1, A2 and A3, the participants will receive subcutaneous injection, whereas in cohorts A4 and A5 the administration will be performed intravenously.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high levels of fat in the blood typically work by inhibiting enzymes involved in lipid synthesis, enhancing lipid metabolism, or modulating lipid transport. These mechanisms help maintain normal lipid levels, which is crucial for preventing cardiovascular diseases and other metabolic disorders. For healthy subjects, such treatments are important as they ensure the maintenance of optimal lipid profiles, thereby supporting overall health and reducing the risk of future health complications.

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